Item 8. Financial Statements and Supplementary Data
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (BDO USA, P.C.; Boston, Massachusetts; PCAOB ID# 243 )
F-1
Consolidated Balance Sheets as of December 31, 2024 and 2023
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023
F-4
Consolidated Statements of Preferred Stock and Stockholders’ Equity for the Years Ended December 31, 2024 and 2023
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-6
Notes to Consolidated Financial Statements
F-7
33
Report of Independent Registered Public Accounting
Firm
Shareholders and Board of Directors
Phio Pharmaceuticals Corp.
Marlborough, Massachusetts
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Phio Pharmaceuticals
Corp. (the "Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, preferred stock
and stockholders’ equity, and cash flows for each of the years then ended, and the related notes (collectively referred to as the
"consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material
respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for
the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern Uncertainty
The accompanying consolidated financial statements have been prepared assuming
that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered
recurring losses from operations and negative cash flows from operations that raise substantial doubt about its ability to continue as
a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.
We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required
to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material
misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those
risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for
our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the
current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee
and that: (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially
challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the
consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate
opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F- 1
Accounting for Certain Warrants Issued in 2024
As described in Note 8 to the consolidated financial statements, in
July 2024 the Company issued new Series C and Series D warrants to purchase common stock to certain holders of existing warrants in connection
with an Inducement Letter Agreement (the “July 2024 Financing”). In December 2024, the Company issued Series E and Series
F warrants to purchase common stock to certain institutional and accredited investors in connection with registered direct offerings of
common stock and concurrent private placement offerings of warrants to purchase common stock (the "December 2024 Offerings”).
The Company first assessed the warrants and determined they were outside the scope of ASC 480 as there were no instances outside of the
Company’s control that could require cash settlement. The Company then applied the applicable accounting guidance in ASC 815 to
account for the warrants as either derivative liabilities or equity instruments. Warrants issued in connection with the July 2024 Financing
and December 2024 Offerings did not meet the definition of a derivative instrument as they are indexed to the Company’s stock and
are classified within stockholders’ equity.
We identified the assessment of the accounting for the Series C, D,
E and F warrants (“Certain Warrants”) to purchase common stock issued in connection with the July 2024 Financing and December
2024 Offerings as a critical audit matter. Determining whether the Certain Warrants issued are in the scope of ASC 480 and whether these
warrants should be accounted for as either derivative liabilities or equity instruments requires significant judgment due to the application
of complex accounting guidance in evaluating whether there were no instances outside of the Company’s control that could require
cash settlement and whether they are indexed to the Company’s stock and classified within stockholders’ equity. Auditing these
elements involved especially challenging and complex auditor judgment due to the nature and extent of the audit effort required to address
the matter, including the need for expertise in accounting for warrants.
The primary procedures we performed to address this critical audit matter
included:
·
Reading and analyzing agreements related to the Certain Warrants issued
to identify relevant terms and conditions that affect whether they are in the scope of ASC 480 or should be accounted for as either derivative
liabilities or equity instruments.
·
With the assistance of professionals in our firm having expertise in accounting
for warrants, we evaluated the Company’s conclusions regarding whether the Certain Warrants issued are in the scope of ASC 480 or
should be accounted for as either derivative liabilities or equity instruments under accounting principles generally accepted in the United
Stated of America.
/s/ BDO USA, P.C.
We have served as the Company's auditor since 2011.
Boston, Massachusetts
March 31, 2025
F- 2
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
December 31,
2024
December 31,
2023
ASSETS
Current assets:
Cash and cash equivalents
$ 5,382
$ 8,490
Prepaid expenses and other current assets
354
832
Total current assets
5,736
9,322
Right of use asset
–
33
Property and equipment, net
2
6
Other assets
–
3
Total assets
$ 5,738
$ 9,364
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 253
$ 657
Accrued expenses
762
942
Lease liability
–
35
Total current liabilities
1,015
1,634
Total liabilities
1,015
1,634
Commitments and Contingencies (Footnote 6)
–
Series D Preferred Stock, $ 0.0001 par value; 10,000,000 shares authorized, 0 issued and outstanding at December 31, 2024 and December 31, 2023
–
–
Stockholders’ equity:
Common stock, $ 0.0001 par value, 100,000,000 shares authorized; 1,733,717 and 416,368 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively
–
–
Additional paid-in capital
151,079
146,936
Accumulated deficit
( 146,356 )
( 139,206 )
Total stockholders’ equity
4,723
7,730
Total liabilities, preferred stock and stockholders’ equity
$ 5,738
$ 9,364
See accompanying notes to consolidated financial statements.
F- 3
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share
data)
Year Ended
December 31,
2024
2023
Operating expenses:
Research and development
$ 3,643
$ 6,332
General and administrative
3,744
4,366
Loss on impairment of property and equipment
–
126
Total operating expenses
7,387
10,824
Operating loss
( 7,387 )
( 10,824 )
Interest income (expense), net
231
( 8 )
Other income
6
6
Net loss
$ ( 7,150 )
$ ( 10,826 )
Net loss per common share:
Basic and diluted
$ ( 9.08 )
$ ( 46.76 )
Weighted average number of common shares outstanding
Basic and diluted
787,466
231,508
See accompanying notes to consolidated financial statements.
F- 4
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
(Amounts in thousands, except share data)
Series
D Preferred Stock
Common
Stock
Additional
Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2022
1
$ 2
126,558
$ –
$ 139,218
$ ( 128,380 )
$ 10,838
Cash-in-lieu of fractional shares for reverse stock split
–
–
( 190 )
–
( 11 )
–
( 11 )
Redemption of preferred stock
( 1 )
( 2 )
–
–
–
–
–
Issuance of common stock and warrants, net of offering costs
–
–
218,168
–
7,452
–
7,452
Issuance of common stock upon exercise of warrants
–
–
69,881
–
–
–
–
Issuance of common stock upon vesting of restricted stock units
–
–
2,601
–
–
–
–
Shares withheld for payroll taxes
–
–
( 650 )
–
( 26 )
–
( 26 )
Stock-based compensation expense
–
–
–
–
303
–
303
Net loss
–
–
–
–
–
( 10,826 )
( 10,826 )
Balance at December 31, 2023
–
–
416,368
–
146,936
( 139,206 )
7,730
Issuance of common stock upon exercise of warrants
–
–
420,578
–
–
–
–
Issuance of common stock upon vesting of restricted stock units
–
–
3,995
–
–
–
–
Shares withheld for payroll taxes
–
–
( 689 )
–
( 5 )
–
( 5 )
Cash issued in lieu of fractional
shares for 1:9 reverse stock split
–
–
( 255 )
–
( 1 )
–
( 1 )
Issuance of common stock and warrants, net of offering costs
–
–
893,720
–
4,002
–
4,002
Stock-based compensation expense
–
–
–
–
147
–
147
Net loss
–
–
–
–
–
( 7,150 )
( 7,150 )
Balance at December 31, 2024
–
$ –
1,733,717
$ –
$ 151,079
$ ( 146,356 )
$ 4,723
See accompanying notes to consolidated financial statements.
F- 5
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Year Ended
December 31,
2024
2023
Cash flows from operating activities:
Net loss
$ ( 7,150 )
$ ( 10,826 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
2
56
Amortization of right of use asset
33
128
Impairment of property and equipment
–
126
Net loss on the disposal of property and equipment
( 6 )
–
Stock-based compensation
147
303
Changes in operating assets and liabilities:
Prepaid expenses and other assets
481
( 196 )
Accounts payable
( 404 )
( 122 )
Accrued expenses
( 180 )
( 83 )
Lease liability
( 35 )
( 135 )
Net cash used in operating activities
( 7,112 )
( 10,749 )
Cash flows from investing activities:
Cash paid for purchase of property and equipment
( 1 )
( 5 )
Asset sale proceeds
9
–
Net cash provided by (used in) investing activities
8
( 5 )
Cash flows from financing activities:
Net proceeds from the issuance of common stock and warrants
4,002
7,452
Cash-in-lieu of fractional shares for reverse stock split
( 1 )
( 11 )
Redemption of Series D Preferred Stock
–
( 2 )
Payment of taxes on net share settlements of restricted stock units
( 5 )
( 26 )
Net cash provided by financing activities
3,996
7,413
Net decrease in cash and cash equivalents
( 3,108 )
( 3,341 )
Cash and cash equivalents at the beginning of year
8,490
11,831
Cash and cash equivalents at the end of year
$ 5,382
$ 8,490
2024
2023
Supplemental cash flow information
Cash paid during the year for:
Interest
$ 13
$ 11
See accompanying notes to consolidated financial statements.
F- 6
PHIO PHARMACEUTICALS CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Significant Accounting Policies
Nature of Operations
Phio Pharmaceuticals Corp. (“ Phio ”
or the “ Company ”) is a clinical stage biotechnology company whose proprietary INTASYL™ self-delivering RNAi technology
is designed to make immune cells more effective in killing tumor cells. The Company is developing therapeutics that are designed to leverage
INTASYL to precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations
or drug delivery systems.
Phio was incorporated in the state of Delaware in 2011
as RXi Pharmaceuticals Corporation. On November 19, 2018, the Company changed its name to Phio Pharmaceuticals Corp., to reflect its transition
from a platform company to one that is fully committed to developing groundbreaking immuno-oncology therapeutics.
Basis of Presentation
The accompanying consolidated financial statements
have been prepared in accordance with accounting principles generally accepted in the United States of America (“ GAAP ”).
Principles of Consolidation
The consolidated financial statements include the accounts
of the Company and its wholly-owned subsidiary, MirImmune, LLC. All material intercompany accounts have been eliminated in consolidation.
Segments
The Company operates as one operating
segment and all assets are located in the United States.
Reverse Stock Split
E ffective
July 5, 2024, the Company completed a 1-for-9 reverse stock split of the Company’s outstanding common stock, including
reclassifying an amount equal to the reduction in par value to additional paid-in capital. The reverse stock split did not reduce the
number of authorized shares of the Company’s common or preferred stock. All share and per share amounts have been adjusted to give
effect to the reverse stock split.
Uses of Estimates in Preparation of Financial Statements
The preparation of financial statements in accordance
with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. The areas subject to significant estimates and judgement include, among others, those related to the fair value
of equity awards, accruals for research and development expenses, useful lives of property and equipment, and the valuation allowance
on our deferred tax assets. On an ongoing basis the Company evaluates its estimates and bases its estimates on historical experience and
other relevant assumptions that the Company believes are reasonable under the circumstances. Actual results could differ materially from
these estimates.
F- 7
Liquidity
The
Company has reported recurring losses from operations since its inception and expects to continue to have negative cash flows from operations
for the foreseeable future. Historically, the Company’s primary source of funding has been from sales of its securities. The Company’s
ability to continue to fund its operations is dependent on obtaining funding from third parties, such as proceeds from the issuance of
debt, sale of equity, or strategic opportunities. This is dependent on a number of factors, including the market demand and l iquidity
of Common Stock. There is no guarantee that debt, additional equity or other funding will be available to us on acceptable terms, or at
all. If the Company fails to obtain additional funding when needed, the Company would be forced to scale back or terminate its operations
or seek to merge with or to be acquired by another company.
The Company has limited cash resources, has reported
recurring losses from operations since inception, negative operating cash flows and has not yet received product revenues. These factors
raise substantial doubt regarding the Company’s ability to continue as a going concern, and the Company’s current cash resources
may not provide sufficient capital to fund operations for at least the next 12 months from the date of the release of these consolidated
financial statements. The continuation of the Company as a going concern depends upon the Company’s ability to raise additional
capital through an equity offering, debt offering and/or strategic opportunity to fund its operations. There can be no assurance that
the Company will be successful in accomplishing these plans in order to continue as a going concern. These consolidated financial statements
do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that
might be necessary should the Company be unable to continue as a going concern.
Concentrations of Credit Risk
Financial instruments that potentially subject the
Company to concentrations of credit risk consist principally of cash. The Company maintains cash balances in several accounts with a reputable
financial institution that management believes is creditworthy, and which at times are in excess of federally insured limits. These accounts
are insured by the Federal Deposit Insurance Corporation for up to $ 250,000 per institution.
Property and Equipment
Property and equipment are stated at cost and depreciated
using the straight-line method based on the estimated useful lives of the related assets. The Company provides for depreciation over the
assets’ estimated useful lives as follows:
Schedule of estimated useful lives
Computer equipment
3 years
Machinery & equipment
5 years
Furniture & fixtures
5 years
Leasehold improvements
Lesser of lease term or 5 years
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment
annually or whenever an event or change in circumstance occurs in which the related carrying amounts may not be recoverable. An impairment
loss would be recognized based on the difference between the carrying value of the asset and its estimated fair value, which would be
determined based on either discounted future cash flows or other appropriate fair value methods.
Leases
At the inception of a contract, the Company determines
whether the contract is or contains a lease based on all relevant facts and circumstances. For contracts that contain a lease, the Company
identifies the lease and non-lease components, determines the consideration in the contract and classifies the lease as operating or financing.
For leases with a term greater than one year, the Company recognizes a liability to make lease payments and an asset representing the
right to use the underlying asset during the lease term at the commencement date of the lease.
F- 8
Lease liabilities and the corresponding right of use
assets are recorded based on the present value of lease payments to be made over the lease term. The discount rate used to calculate the
present value is the rate implicit in the lease, or if not readily determinable, the Company’s incremental borrowing rate. The Company’s
incremental borrowing rate is the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar
term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right of use asset may be required
for items such as initial direct costs or incentives received. Lease payments on operating leases, including scheduled increases, are
recognized on a straight-line basis over the expected term of the lease. Lease payments on financing leases are recognized using the effective
interest method.
Fair Value of Financial Instruments
The carrying amounts of cash,
accounts payable and accrued expenses of the Company approximate their fair values due to their short-term nature.
Derivative Financial Instruments
Financial instruments that meet the definition of a
derivative are classified as an asset or liability and measured at fair value on the issuance date and are revalued on each subsequent
balance sheet date. The changes in fair value are recognized as current period income or loss. Financial instruments that do not meet
the definition of a derivative are classified as equity and measured at fair value and recorded as additional paid-in capital in stockholders’
equity at the date of issuance. No further adjustments to their valuation are made.
Research and Development Expenses
Research and development expenses relate to compensation
and benefits for research and development personnel, facility-related expenses, supplies, external services, costs to acquire technology
licenses, research activities under our research collaborations, expenses associated with preclinical and clinical development activities
and other operating costs. Research and development expenses are charged to expense as incurred. Payments made by the Company in advance
for research and development services not yet provided and/or for materials not yet received are recorded as prepaid expenses and expensed
when the service has been performed or when the goods have been received.
Accrued liabilities are recorded related to those expenses
for which vendors have not yet billed the Company with respect to services provided and/or materials that it has received. Accrued liabilities
for the services provided by contract research organizations are recorded during the period incurred based on such estimates and assumptions
as expected cost, passage of time, the achievement of milestones and other information available to us and are assessed on a quarterly
basis. Actual results may differ from these estimates and could have a material impact on the Company’s reported results. The Company’s
historical accrual estimates have not been materially different from its actual costs.
Collaborative Arrangements
The Company follows the provisions of the Financial
Accounting Standards Board (the “ FASB ”) Accounting Standards Codification (“ ASC ”) Topic 808, “ Collaborative
Arrangements ,” (“ Topic 808 ”) when collaboration agreements involve joint operating activities in which both
parties are active participants and that are also both exposed to significant risks and rewards. The Company also considers the guidance
in the FASB ASC Topic 606, “ Revenue from Contracts with Customers ,” (“ Topic 606 ”) in determining
the appropriate treatment for activities between the Company and its collaborative partners that are more reflective of a vendor-customer
relationship and therefore, within the scope of Topic 606. Under Topic 808, the Company determines an appropriate recognition method,
either by analogy to appropriate accounting literature or by applying a reasonable accounting policy election. Generally, the classification
of transactions under the collaborative arrangements is determined based on the nature and contractual terms of the arrangement along
with the nature of the operations of the participants. The Company recognizes its share of costs arising from research and development
activities performed by collaborators in the period its collaborators incur such expense. Reimbursements that are the result of a collaborative
relationship instead of a customer relationship, such as co-development activities, are evaluated on a quarterly basis and recorded as
an offset to research and development expense incurred. Payments in excess of our collaboration expense will be recorded as revenue.
F- 9
Patents and Patent Application Costs
Although the Company believes that its patents and
underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are,
therefore, expensed as general and administrative costs as incurred.
Stock-based Compensation
The Company follows the provisions of the FASB ASC
Topic 718, “ Compensation — Stock Compensation ” (“ ASC 718 ”), which requires the measurement
and recognition of compensation expense for all stock-based payment awards. The fair value of RSUs is based upon the Company’s closing
stock price at the grant date. The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at
the grant date. The Black-Scholes valuation model requires the input of valuation assumptions to calculate the value of stock options,
including expected volatility, expected term, risk-free interest rate and expected dividends. Stock-based compensation expense is recognized
on a straight-line basis over the requisite service period, which generally represents the vesting period, and commences at the date of
grant based on the fair value of the award.
Stock-based compensation expense recognized in the
consolidated financial statements is based on awards that are ultimately expected to vest. Accordingly, the Company is also required to
estimate forfeitures at the time of grant and to revise those estimates in subsequent periods if actual forfeitures differ from estimates.
The Company uses historical data to estimate pre-vesting award forfeitures and record stock-based compensation expense only for those
awards that are expected to vest. The Company’s forfeiture rate estimates are based on an analysis of our actual forfeiture experience,
employee turnover behavior, and other factors. The impact of any adjustments to the Company’s forfeiture rates or to the extent
that actual forfeitures differ from the Company’s estimates, is recorded as a cumulative adjustment in the period the estimates
are revised.
Income Taxes
The Company recognizes assets or liabilities for the
deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts in the consolidated
financial statements in accordance with the FASB ASC Topic 740, “Accounting for Income Taxes” (“ ASC 740 ”) .
These temporary differences will result in taxable or deductible amounts in future years when the reported amounts of the assets or liabilities
are recovered or settled. Those temporary differences referred to as deferred tax assets and liabilities are determined at the end of
each period using the tax rate expected to be in effect when taxes are actually paid or recovered. Valuation allowances are established
if, based on the weight of available evidence, it is more likely than not that all or a portion of a deferred tax asset will not be realized.
The provision for income taxes, if any, represents the tax payable for the period and the change in deferred income tax assets and liabilities
during the period.
The recognition and measurement of benefits related
to the Company’s tax positions requires significant judgment, as uncertainties often exist with respect to new laws, new interpretations
of existing laws, and rulings by taxing authorities. The Company follows a more-likely-than not threshold for financial statement recognition
and measurement of a tax position taken, or expected to be taken in a tax return. The guidance relates to, amongst other things, classification,
accounting for interest and penalties associated with tax positions, and disclosure requirements. Any interest and penalties accrued related
to uncertain tax positions are recorded as income tax expense. Differences between actual results and the Company’s assumptions
or changes in the Company’s assumptions in future periods are recorded in the period they become known.
Comprehensive Loss
The Company’s comprehensive loss is equal to
its net loss for all periods presented.
Net Loss per Share
Basic net loss per share is computed by dividing net
loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing the Company’s
net loss by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares outstanding,
except where such dilutive potential common shares would be anti-dilutive. Dilutive potential common shares primarily consist of warrants,
RSUs and stock options.
F- 10
Recently adopted accounting pronouncements
In November 2023, the Financial Accounting Standards Board (“ FASB ”)
issued Accounting Standards Update (“ ASU ”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable
Segments,” which aims to improve financial reporting by requiring disclosure of incremental segment information on an annual and
interim basis for all public entities to enable investors to develop more decision-useful financial analyses. The amendments in this ASU
do not change how a public entity identifies its operating segments, aggregates those operating segments, or applies the quantitative
thresholds to determine its reportable segments. This ASU is effective for fiscal years beginning after December 15, 2023, and interim
periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company adopted ASU 2023-07 during the
year ended December 31, 2024, which resulted in the required additional disclosures included in Note 12 to the Company’s consolidated
financial statements.
Recent Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic
740): Improvements to Income Tax Disclosures,” which requires public business entities to disclose additional information in specified
categories with respect to the reconciliation of the effective tax rate to the statutory rate for federal, state, and foreign income taxes.
It also requires greater detail about individual reconciling items in the rate reconciliation to the extent the impact of those items
exceeds a specified threshold. In addition to new disclosures associated with the rate reconciliation, the ASU requires information pertaining
to taxes paid (net of refunds received) to be disaggregated for federal, state, and foreign taxes and further disaggregated for specific
jurisdictions to the extent the related amounts exceed a quantitative threshold. The ASU also describes items that need to be disaggregated
based on their nature, which is determined by reference to the item’s fundamental or essential characteristics, such as the transaction
or event that triggered the establishment of the reconciling item and the activity with which the reconciling item is associated. The
ASU eliminates the historic requirement that entities disclose information concerning unrecognized tax benefits having a reasonable possibility
of significantly increasing or decreasing in the 12 months following the reporting date. This ASU is effective for annual periods beginning
after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for
issuance. This ASU should be applied on a prospective basis; however, retrospective application is permitted. The Company is currently
evaluating the impact that ASU 2023–09 will have on its consolidated financial statements.
In November 2024, the FASB issued Accounting Standards Update ASU 2024-03,
“Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosure (Subtopic 220-40): Disaggregation of Income
Statement Expenses,” which requires additional disclosure about the specific expense categories in the notes to financial statements
at interim and annual reporting periods. The amendments in this ASU do not change or remove current expense disclosure requirements but
affect where this information appears in the notes to financial statements. This ASU is effective for annual reporting periods beginning
after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. Upon adoption,
the guidance can be applied prospectively or retrospectively. The Company is currently evaluating the impact that ASU 2024-03 will have
on its consolidated financial statements.
2. Collaboration Agreement
AgonOx, Inc. (“ AgonOx ”)
In February 2021, the Company entered into a clinical
co-development collaboration agreement (the “ Clinical Co-Development Agreement ”) with AgonOx, a private company developing
a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer. Under the Clinical Co-Development Agreement,
Phio and AgonOx were working to develop a T cell-based therapy using the Company’s lead product candidate, PH-762, and AgonOx’s
“double positive” tumor infiltrating lymphocytes (“ DP TIL ”) technology. Per the terms of the Clinical Co-Development
Agreement, the Company agreed to reimburse AgonOx up to $ 4,000,000 in expenses incurred to conduct a Phase 1 clinical trial of PH-762
treated DP TIL in patients with advanced melanoma and other advanced solid tumors.
F- 11
In May 2024, the Company terminated the Clinical Co-Development
Agreement with AgonOx effective immediately. Effective as of the date of termination, the Clinical Co-Development Agreement and the Company’s
continuing obligations and those of AgonOx thereunder were terminated in their entirety. The Company no longer is required to provide
financial support for the development costs incurred in the Clinical Co-Development Agreement and the Company is no longer entitled to
future development milestones or royalty payments from AgonOx’s licensing of its DP TIL technology. The Company will pay to AgonOx
all payment obligations that accrued prior to the termination of the Clinical Co-Development Agreement. Remaining payments to be made
to AgonOx as of December 31, 2024 totaled $34,320, which primarily relate to accrued obligations for patient fees and other miscellaneous
costs as of the date of termination. Pursuant to the terms of the Clinical Co-Development Agreement, each of the Company and AgonOx shall
be responsible for its own costs and expenses incurred in connection with the wind-down of the Phase 1 clinical trial.
The Company recognized approximately $ 106,000 and $ 1,115,000
of research and development expense in connection with these efforts during the years ended December 31, 2024 and 2023, respectively.
3. Property and Equipment
The following table summarizes the Company’s
major classes of property and equipment, in thousands:
Schedule of property and equipment
December 31,
2024
2023
Computer equipment
$ 35
$ 62
Machinery & equipment
265
964
Furniture & fixtures
8
70
Leasehold improvements
–
46
Total gross fixed assets
308
1,142
Less: accumulated depreciation and amortization
( 306 )
( 1,136 )
Property and equipment, net
$ 2
$ 6
Depreciation and amortization expense for the years
ended December 31, 2024 and 2023 was $ 2,000 and $ 56,000 , respectively.
4. Accrued Expenses
Accrued expenses consist of the following, in thousands:
Schedule of accrued expenses
December 31,
2024
2023
Compensation and benefits
$ 31
$ 222
Professional fees
156
126
Research and development costs
558
517
Other
17
77
Total accrued expenses
$ 762
$ 942
F- 12
5. Leases
The Company leases space for various corporate and
research purposes. It is the Company’s policy to apply the provisions of ASC 842 when accounting for arrangements that meet the
criteria to be a lease. The Company calculates the lease liability as the present value of the lease’s cash flows using the interest
rate implicit in the lease, if determinable. If the rate implicit in the lease is not determinable, the Company uses its incremental borrowing
rate. The incremental borrowing rate is defined as the rate the Company would have to pay to borrow on a collateralized basis over the
lease term. The Company has elected the accounting policy election available under ASC 842 to not record a lease liability for leases
with a term of less than one year.
From April 2014 to March 2024, the Company leased
space that was utilized as its corporate headquarters and primary laboratory. The lease expired on March 31, 2024. On March 1, 2024,
the Company commenced a lease for a laboratory facility located at 17 Briden Street, Worcester, Massachusetts. The lease had an
original expiration date of August
31, 2024 and was subsequently extended through February 28, 2025 . The Company continues to lease the space on a month-to-month basis. Monthly rent is approximately $ 2,500 .
The lease for the Company’s corporate headquarters
had represented all of its significant lease obligations. The amounts reported in the 2023 consolidated balance sheets for the operating
lease in which the Company is the lessee and other supplemental balance sheet information is set forth as follows, in thousands, except
the lease term (number of years) and discount rate:
Schedule of lease amount recorded in balance sheet
December 31,
2024
2023
Assets
Right of use asset
$ –
$ 33
Liabilities
Lease liability, current
–
35
Lease liability, non-current
–
–
Total lease liability
$ –
$ 35
Lease Term and Discount Rate
Weighted average remaining lease term
–
0.25
Weighted average discount rate
–
4.70 %
Operating lease costs included in operating expense
were $ 58,000 and $ 132,000 for the years ended December 31, 2024 and 2023, respectively.
Cash paid for the amounts included in the measurement
of the operating lease liability on the Company’s consolidated balance sheets and included within changes in the lease liability
in the operating activities of the Company’s consolidated statements of cash flows was $ 60,000 and $ 139,000 for the years ended
December 31, 2024 and 2023, respectively.
6. Commitments and Contingencies
Commitments
In February 2021, the Company
entered into the Clinical Co-Development Agreement with AgonOx to develop a T cell-based therapy using the Company’s lead product
candidate, PH-762, and AgonOx’s DP TIL technology. Per the terms of the Clinical Co-Development Agreement, the Company agreed to
reimburse AgonOx up to $ 4,000,000 in expenses incurred to conduct a Phase 1 clinical trial of PH-762 treated DP TIL in patients with advanced
melanoma and other advanced solid tumors. In May 2024, the Company terminated the Clinical Co-Development Agreement with AgonOx effective
immediately. Refer to Note 2 for further details on the Clinical Co-Development Agreement with AgonOx.
F- 13
In September 2011, the Company entered into an agreement
with Advanced RNA Technologies, LLC (“ Advirna ”), pursuant to which Advirna assigned to the Company its existing patent
and technology rights related to the INTASYL technology in exchange for an annual maintenance fee of $ 100,000 , a one-time milestone payment
upon the future issuance of the first patent with valid claims covering the assigned patent and technology rights and the issuance of
shares of Common Stock equal to 5 % of the Company’s fully-diluted shares outstanding at the time of issuance. The one-time milestone
payment and the issuance of shares of Common Stock were completed in 2014 and 2012, respectively. Additionally, the Company is required
to pay low single-digit royalties to Advirna on any licensing revenue received by the Company with respect to future licensing of the
assigned Advirna patent and technology rights. To date, any royalties owed to Advirna under the Advirna agreement have been minimal.
The Company’s rights under the Advirna agreement
will expire upon the later of: (i) the expiration of the last-to-expire of the “patent rights” (as defined therein) included
in the Advirna agreement; and (ii) the abandonment of the last-to-be abandoned of such patents, unless earlier terminated in accordance
with the provisions of the Advirna agreement. Further, the Company also granted back to Advirna a license under the assigned patent and
technology rights for fields of use outside human therapeutics.
As part of its business, the Company may enter into
licensing agreements with third parties that require milestone and royalty payments based on the progress of the asset through development
stages. Milestone payments may be required, for example, upon progress through clinical trials, upon approval of the product by a regulatory
agency and/or upon a percentage of sales of the product pursuant to such agreements. The expenditures required under these arrangements
may be material individually in relation to any product candidates covered by the intellectual property licensed under any such arrangement,
and material in the aggregate in the unlikely event that milestones for multiple products covered by these arrangements were reached in
the same period. Due to the contingent nature of these payments, they are not included in the table of contractual obligations shown below.
During the years ended December 31, 2024 and 2023,
the Company did no t trigger any milestone payments.
The Company’s contractual license obligations
that will require future cash payments as of December 31, 2024, which result from payments expected in connection with annual license
fees, are as follows, in thousands:
Schedule of future cash payments for contractual license obligations
Year Ending December 31,
2025
$ 100
2026
100
2027
100
2028
100
2029
100
Total
$ 500
The Company applies the disclosure provisions of the
FASB ASC Topic 460, “ Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of
Indebtedness of Others ” (“ ASC 460 ”), to its agreements that contain guarantee or indemnification clauses.
The Company provides: (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered
or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope
and size to officers and directors against third-party claims arising from the services they provide to us. These indemnifications give
rise only to the disclosure provisions of ASC 460. To date, the Company has not incurred costs as a result of these obligations and does
not expect to incur material costs in the future. Accordingly, the Company has not accrued any liabilities in its consolidated financial
statements related to these indemnifications.
F- 14
Litigation
From time to time, the Company may become a party to
various legal proceedings and complaints arising in the ordinary course of business. To the Company’s knowledge, it is not currently
a party to any actual or threatened material legal proceedings. Accordingly, there were no contingent liabilities recorded as of the year
ended December 31, 2024.
7. Preferred Stock
The Company has authorized up to 10,000,000 shares
of preferred stock, $ 0.0001 par value per share, for issuance. The Company’s Board of Directors (the “ Board ”)
is authorized under the Company’s Amended and Restated Certificate of Incorporation (as may be amended and/or restated from time
to time, the “ Amended Certificate ”), to designate the authorized preferred stock into one or more series and to fix
and determine such rights, preferences, privileges and restrictions of any series of preferred stock, including voting rights, dividend
rights, conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Board upon its issuance.
In November 2022, the Company sold one share of Series
D Preferred Stock, par value $ 0.0001 per share (the “ Series D Preferred Stock ”) to Robert Bitterman, then its interim
Executive Chairman and current Chief Executive Officer, for $ 1,750 . The Series D Preferred Stock was not convertible into, or exchangeable
for, shares of any other class or series of stock or other securities of the Company; had no rights with respect to any distribution of
assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up
of the Company, whether voluntarily or involuntarily; and was not entitled to receive dividends of any kind.
The Series D Preferred Stock is entitled to 17,500,000
votes per share exclusively with respect to any proposal to amend the Company’s Amended Certificate to effect a reverse stock split
of Common Stock. The terms provide that it would be voted, without action by the holder, on any such proposal in the same proportion as
shares of Common Stock are voted. The Series D Preferred Stock otherwise has no voting rights except as otherwise required by the General
Corporation Law of the State of Delaware.
Under its terms, the outstanding share of Series D
Preferred Stock was to be redeemed in whole, but not in part, at any time: (i) if such redemption was approved by the Board in its sole
discretion or (ii) automatically and effective upon the approval by the Company's stockholders of an amendment to the Amended Certificate
to effect a reverse stock split of Common Stock. The Series D Preferred Stock was redeemed in whole on January 4, 2023, upon the approval
by the Company’s stockholders of the 2023 1-for-12 reverse stock split. Upon such redemption, the holder of the Series D Preferred Stock received
consideration of $ 1,750 in cash.
At December 31, 2024, there were no shares of preferred
stock issued or outstanding.
8. Stockholders’ Equity
The Company raised $ 4 .0 million and $ 7.5 million through
a series of warrants inducements, registered direct offerings, and concurrent private placements during the years ended December 31, 2024
and 2023, respectively.
April 2023 Financing
In April 2023, the Company completed a registered direct
offering and a concurrent private placement of a total of: 353,983 registered shares of Common Stock at a purchase price per
share of $ 5.65 , unregistered five and one-half year term Series A warrants to purchase up to 353,983 shares of Common Stock
at an exercise price of $ 5.40 per share and unregistered eighteen month term Series B warrants to purchase up to 353,983 shares
of Common Stock at an exercise price of $ 5.40 per share (collectively, the “ April 2023 Financing ”). In addition,
the Company issued unregistered warrants to the placement agent, H.C. Wainwright & Co., LLC (“ HCW ”), in the April
2023 Financing to purchase a total of 26,549 shares of Common Stock at an exercise price of $ 7.0625 per share. Net proceeds
to the Company from the April 2023 Financing were $ 1,538,000 after deducting placement agent fees and offering expenses.
F- 15
In connection with the April 2023 Financing, the Company
entered into warrant amendment agreements (the “ Warrant Amendment Agreements ”) with the participating investors to
amend the exercise price of certain existing warrants to purchase up to an aggregate of 191,619 shares of Common Stock that
were previously issued in April 2018 through January 2021, such that each of the amended warrants had an exercise price of $ 5.40 per
share. The Company received $ 24,000 as consideration in connection with the Warrant Amendment Agreements. The Company assessed the
amendments to the exercise price of the warrants under the FASB ASC Topic 815, “Derivatives and Hedging” (“ ASC 815 ”)
and determined that the amendment to the exercise price was completed in connection with and contingent on the close of the April 2023
Financing. The increase in fair value of $ 293,000 related to the Warrant Amendment Agreements was recognized as an equity issuance
cost and recorded in additional paid in capital per ASC 815.
June 2023 Financing
In June 2023, the Company completed a registered direct
offering and a concurrent private placement of a total of: 233,646 registered shares and 72,000 unregistered shares
of Common Stock each at a purchase price per share of $ 4.28 , unregistered pre-funded warrants to purchase up to an aggregate of 628,935 shares
of Common Stock at a purchase price per share of $ 4.279 and with an exercise price of $ 0.001 per share, unregistered five and
one-half year term Series A warrants to purchase up to an aggregate of 934,581 shares of Common Stock at an exercise price of
$ 4.03 per share and unregistered eighteen month term Series B warrants to purchase up to an aggregate of 934,581 shares
of Common Stock at an exercise price of $ 4.03 per share (collectively, the “ June 2023 Financing ”). In addition,
the Company issued unregistered warrants to the placement agent, HCW, in the June 2023 Financing to purchase a total of 70,094 shares
of Common Stock at an exercise price of $ 5.35 per share. Net proceeds to the Company from the June 2023 Financing were $ 3,510,000 after
deducting placement agent fees and offering expenses.
December 2023 Financing
In December 2023, the Company entered into an inducement
letter agreement (the “ Inducement Letter Agreement ”) with certain holders of the Company’s existing warrants
to purchase up to an aggregate of 2,130,252 shares of Common Stock. The existing warrants were originally issued on dates between
October 2018 and June 2023 with an exercise price of $5.40 or $4.03 per share. Pursuant to the Inducement Letter Agreement,
these warrants were exercised for cash at a reduced exercise price of $1.33 per share in consideration of the Company’s agreement
to issue new five and one-half year term Series A warrants to purchase up to 2,270,320 shares of Common Stock at an exercise
price of $1.08 per share and new eighteen month term Series B warrants to purchase up to 1,990,184 shares of Common Stock
at an exercise price of $1.08 per share (collectively, the “ December 2023 Financing ”). In addition, the Company
issued warrants to the placement agent, HCW, in the December 2023 Financing to purchase a total of 159,769 shares of Common
Stock at an exercise price of $1.66 per share.
Pursuant to the terms of the Inducement Letter Agreement,
in the event that the exercise of the existing warrants in the December 2023 Financing would have otherwise caused a holder to exceed
the beneficial ownership limitations set forth in the existing warrant, the Company issued the number of shares that would not cause a
holder to exceed such beneficial ownership limitation and agreed to hold such balance of shares of Common Stock in abeyance. Accordingly,
at December 31, 2023, an aggregate of 826,370 shares of Common Stock were held in abeyance (the “ December 2023 Abeyance
Shares ”) with such December 2023 Abeyance Shares evidenced through the holder’s existing warrants and which are deemed
to be prepaid. The December 2023 Abeyance Shares will be held until notice is received by the holder that the balance of the shares of
Common Stock may be issued in compliance with such beneficial ownership limitations and may be exercised pursuant to a notice of exercise
from the holder. Until such time, the December 2023 Abeyance Shares are evidenced through the holder’s existing warrants and have
been included in the Company’s table of outstanding warrants below.
Net proceeds to the Company from the December 2023
financing were $ 2,404,000 after deducting placement agent fees and offering expenses. The Company assessed the amendments to the
exercise price of the warrants under the ASC 815 and determined that the amendment to the exercise price was completed in connection with
and contingent on the close of the December 2023 Financing. The increase in fair value of $ 412,000 related to the modification of
the terms of the warrants to induce exercise was recognized as an equity issuance cost and recorded in additional paid in capital per
ASC 815.
F- 16
May 2024 Financing
On May 16, 2024, the Company entered into a
purchase agreement (the “ Purchase Agreement ”) with Triton Funds LP (“ Triton ”), pursuant to
which the Company agreed to sell, and Triton agreed to purchase, upon the Company’s request in one or more transactions, up
to 862,500
shares of Common Stock at a purchase price of $ 0.72 per
share (the “ Purchase Price ”), for aggregate gross proceeds of up to $ 621,000 .
The Company recorded expense of approximately $100,000, primarily related to legal fees, in connection with the execution of the
Purchase Agreement with Triton. On July 3, 2024, the Company terminated the Purchase Agreement with Triton effective immediately. No
shares of Common Stock were sold by the Company pursuant to the Purchase Agreement prior to termination.
July 2024 Financing
On July 11, 2024, the Company entered into
inducement letter agreements (the “ July 2024 Inducement Letter Agreements ”) with certain holders of certain of
the Company’s existing warrants to purchase up to an aggregate of 545,286 shares of Common Stock. The existing
warrants were originally issued in February 2020 through December 2023, having exercise prices between $324.00 and $9.72 per share.
Pursuant to the July 2024 Inducement Letter Agreements, these warrants were exercised for cash at a reduced exercise of $ 5.45 per
share in consideration of the Company’s agreement to issue new unregistered five and one-half year term Series C warrants to
purchase up to 583,098 shares of Common Stock at an exercise price of $ 5.45 and new unregistered eighteen month term
Series D warrants to purchase up to 507,474 shares of Common Stock at an exercise price of $ 5.45 , both issued and sold at
a price of $0.125 per warrant share (the “ July 2024 Financing ”). In addition, the Company issued warrants to the
placement agent, HCW, to purchase a total of 40,896 shares of Common Stock at an exercise price of $6.8125 per share. The net
proceeds to the Company from the July 2024 Financing were approximately $ 2,646,000 , after deducting placement agent fees and
offering expenses. The Company incurred non-cash equity issuance cost of approximately $ 2.4 million for the incremental
fair value of the outstanding equity classified warrants and approximately $ 0.2 million for placement agent warrants.
Pursuant to the terms of the July 2024 Inducement Letter
Agreements, in the event that the exercise of the existing warrants in the July 2024 Financing would have otherwise caused a holder to
exceed the beneficial ownership limitations set forth in the existing warrant, the Company issued the number of shares that would not
cause a holder to exceed such beneficial ownership limitation and agreed to hold such balance of shares of Common Stock in abeyance. Accordingly,
an aggregate of 328,758 shares of Common Stock were held in abeyance (the “ July 2024 Abeyance Shares ”) with
such July 2024 Abeyance Shares evidenced through the holder’s existing warrants and which are deemed to be prepaid. The July 2024
Abeyance Shares were held until notice was received by the holder that the balance of the shares of Common Stock could be issued in compliance
with such beneficial ownership limitations and were exercised pursuant to a notice of exercise from the holder. Until such time, the Abeyance
Shares were evidenced through the holder’s existing warrants and have been included in the Company’s table of outstanding
warrants below. During the year ended December 31, 2024, all of the July 2024 Abeyance Shares were released.
December 19, 2024 Concurrent Registered Direct Offering and Private
Placement
On December 19, 2024, the Company entered into a securities
purchase agreement (the “ December 19, 2024 Securities Purchase Agreement ”) with certain institutional and accredited
investors in connection with a registered direct offering (the “ December 19, 2024 Registered Direct Offering ”) and
concurrent private placement (the “ December 19, 2024 Private Placement ” and, together with the December 19, 2024 Registered
Direct Offering, the “ December 19, 2024 Offerings ”). The December 19, 2024 Offerings closed on December 20, 2024. The
net proceeds to the Company from the December 19, 2024 Offerings were approximately $ 900,000 , after deducting placement agent fees and
offering expenses.
Pursuant to the December 19, 2024 Securities Purchase
Agreement, the Company offered and sold in the December 19, 2024 Registered Direct Offering 437,192 shares of Common Stock at a purchase
price of $ 2.635 per share. In the December 19, 2024 Private Placement, the Company also issued to such institutional and accredited investors
unregistered warrants to purchase up to 437,192 shares of Common Stock (the “ Series E Warrants ”). Under the terms of
the December 19, 2024 Securities Purchase Agreement, for each share of Common Stock issued in the December 19, 2024 Registered Direct
Offering, an accompanying Series E Warrant was issued to the purchaser thereof. Each Series E Warrant is exercisable for one share of
Common Stock at an exercise price of $ 2.51 per share and will expire on December 20, 2029 . The Series E Warrants were offered and sold
at a purchase price of $ 0.125 per Series E Warrant, which purchase price is included in the offering price per share of Common Stock issued
in the December 19, 2024 Registered Direct Offering.
F- 17
December 23, 2024 Concurrent Registered Direct Offering and Private
Placement
On December 23, 2024, the Company entered into a securities
purchase agreement (the “ December 23, 2024 Securities Purchase Agreement ”) with certain institutional and accredited
investors in connection with a registered direct public offering (the “ December 23, 2024 Registered Direct Offering ”)
and concurrent private placement (the “ December 23, 2024 Private Placement ” and, together with the December 23, 2024
Registered Direct Offering, the “ December 23, 2024 Offerings ” and together with the December 19 , 2024 Offerings,
the “December 2024 Offerings”). The December 23, 2024 Offerings closed on December 24, 2024. The net proceeds to the Company
from the December 23, 2024 Offerings were approximately $ 480,000 , after deducting placement agent fees and offering expenses.
Pursuant to the December 23, 2024 Securities Purchase
Agreement, the Company offered and sold in the December 23, 2024 Registered Direct Offering 240,000 shares of Common Stock at a purchase
price of $ 2.00 per share. In the December 23, 2024 Private Placement, the Company also issued to such institutional and accredited investors
unregistered warrants to purchase up to 240,000 shares of Common Stock (the “ Series F Warrants ”). Under the terms of
the December 23, 2024 Securities Purchase Agreement, for each share of Common Stock issued in the December 23, 2024 Registered Direct
Offering, an accompanying Series F Warrant was issued to the purchaser thereof. Each Series F Warrant is exercisable for one share of
Common Stock at an exercise price of $ 2.00 per share and will expire on December 24, 2029 . The Series F Warrants were offered and sold
at a purchase price of $ 0.125 per Series F Warrant, which purchase price is included in the offering price per share of Common Stock issued
in the December 23, 2024 Registered Direct Offering.
In connection with the December 2024 Offerings, the
Company agreed to issue to H.C. Wainwright & Co., LLC (the “Placement Agent”), or its designees, warrants to purchase
up to an aggregate of 50,789 shares of Common Stock (the “Placement Agent Warrants”), which represent 7.5% of the aggregate
number of shares of Common Stock sold in the December 19, 2024 Registered Direct Offering and the December 23, 2024 Registered Direct
Offering. The Placement Agent Warrants have substantially the same terms as the Series E Warrants and the Series F Warrants, except that
(i) 32,789 of the Placement Agent Warrants have an exercise price equal to $3.2938, or 125% of the offering price per share of Common
Stock sold in the December 19, 2024 Registered Direct Offering, and are exercisable until December 19, 2029, and (ii) 18,000 of the Placement
Agent Warrants have an exercise price equal to $2.50, or 125% of the offering price per share of Common Stock sold in the December 23,
2024 Registered Direct Offering, and are exercisable until December 23, 2029.
Warrants
The Company first assessed the warrants in the April
2023 Financing, June 2023 Financing, December 2023 Financing, July 2024 Financing, and December 2024 Offerings under the FASB ASC Topic
480, “ Distinguishing Liabilities from Equity ” (“ ASC 480 ”) to determine whether they were within
the scope of ASC 480. As there were no instances outside of the Company’s control that could require cash settlement, the Company’s
warrants issued in the April 2023 Financing, June 2023 Financing, December 2023 Financing, July 2024 Financing, and December 2024 Offerings
were determined to be outside the scope of ASC 480.
The Company then applied and followed the applicable
accounting guidance in ASC 815. Financial instruments are accounted for as either derivative liabilities or equity instruments depending
on the specific terms of the agreement. The warrants issued in the April 2023 Financing, June 2023 Financing, December 2023 Financing,
July 2024 Financing, and December 2024 Offerings did not meet the definition of a derivative instrument as they are indexed to Common
Stock and classified within stockholders’ equity. Based on this determination, the warrants issued in the April 2023 Financing,
June 2023 Financing, December 2023 Financing, July 2024 Financing, and December 2024 Offerings were classified within stockholders’
equity.
The Company accounted for the 2023 and 2024 placement
agent warrants, issued to H.C. Wainwright & Co., LLC in conjunction with the financings, as issuance costs related to the offering
of the Company’s shares and warrants. These warrants meet the criteria for equity classification.
In addition to the December 2023 Financing, on December
6, 2023, the Company issued 628,935 shares
of Common Stock related to exercises from the pre-funded warrants issued in the June 2023 Financing for proceeds of $ 630 .
F- 18
The following table summarizes the Company’s
outstanding warrants, all of which are classified as equity instruments, at December 31, 2024:
Schedule of warrant activity
Number
of Warrants
Weighted-
Average
Exercise Price
Per Share
Outstanding at December 31, 2022
60,600
$ 490.75
Issued
858,162
19.55
Exercised
( 214,757 )
8.08
Expired
( 475 )
5,621.55
Outstanding at December 31, 2023
703,530
33.09
Issued
1,859,449
4.28
Exercised
( 637,112 )
6.39
Expired
–
–
Outstanding at December 31, 2024
1,925,867
$ 12.66
9. Stock-based Compensation
Stock Plans
The Company’s approved equity plans include
the Phio Pharmaceuticals Corp. 2020 Long Term Incentive Plan (the “ 2020 Plan ”) and the Phio Pharmaceuticals Corp.
2012 Long Term Incentive Plan (the “ 2012 Plan ”). These plans are administered by our Board and provide for the
grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSU awards,
performance stock awards, and performance cash awards. Upon adoption of the 2020 Plan, shares that remained available for grant
under the 2012 Plan and shares that were subject to outstanding awards under the 2012 Plan were included in the authorized shares
available for grant under the 2020 Plan. Further, upon adoption of the 2020 Plan, the Company no longer grants new equity awards
under the 2012 Plan. In July 2024, the Company’s stockholders approved an amendment to the 2020 Plan to increase the number of
shares authorized for issuance thereunder to 110,000,000
shares, consisting of 100,000,000
shares of Common Stock and 10,000,000
shares of Preferred Stock.
As of December 31, 2024, there were 1,126 shares
subject to outstanding stock options and 71,000 shares subject to unvested RSUs.
Restricted Stock Units
RSUs are issued under the Company’s 2020 Plan
or as inducement grants issued outside of the 2020 Plan to new employees. RSUs are generally subject to the satisfaction of certain service
requirements. RSUs granted by the Company to employees generally vest 1 year after the grant date. Upon vesting, each outstanding RSU
will be settled for one share of Common Stock. Employee RSU recipients may elect to net share settle upon vesting, in which case the Company
pays the employee’s income taxes due upon vesting and withholds a number of shares of equal value. The Company does not expect to
repurchase shares to satisfy RSU vests. The fair value of the RSUs awarded is based upon the Company’s closing stock price at the
grant date and is expensed over the requisite service period.
The following table summarizes the activity of the
Company’s RSUs for the year ended December 31, 2024:
Schedule of RSU activity
Number
of Shares
Weighted-
Average
Grant Date Fair Value
Per Share
Unvested units at December 31, 2022
5,257
$ 135.26
Granted
4,836
47.16
Vested
( 2,599 )
134.88
Forfeited
( 1,969 )
88.92
Unvested units at December 31, 2023
5,525
74.83
Granted
71,000
2.77
Vested
( 3,995 )
71.10
Forfeited
( 1,530 )
84.55
Unvested units at December 31, 2024
71,000
$ 2.77
F- 19
The weighted-average fair value of RSUs granted during
the years ended December 31, 2024 and 2023 was $ 2.77 and $ 5.24 , respectively.
Stock-based compensation expense related to RSUs was
$ 141,000 and $ 298,000 for the years ended December 31, 2024 and 2023, respectively.
The aggregate fair value of awards that vested during
the years ended December 31, 2024 and 2023 was $ 21,000 and $ 105,000 , which represents the market value of Common Stock on the date that
the RSUs vested.
As of December 31, 2024, the compensation expense
for all unvested RSUs in the amount of approximately $ 142,000 will be recognized in the Company’s results of operations over a weighted
average period of .95 years.
Stock Options
Stock options are available for issuance under the
2020 Plan or as inducement grants issued outside of the 2020 Plan to new employees. Stock options are generally subject to graded vesting
and the satisfaction of service requirements. Stock options granted by the Company to employees generally vest annually over 4 years after
the grant date and generally vest over 1 year after the grant date for members of the Board of Directors and expire within ten years of
grant. Upon the exercise of a stock option, the Company issues new shares and delivers them to the recipient. The Company does not expect
to repurchase shares to satisfy stock option exercises.
The Company uses the Black-Scholes option-pricing model
to determine the fair value of all its option grants. The risk-free interest rate used for each grant was based upon the yield on zero-coupon
U.S. Treasury securities with a term similar to the expected life of the related option. The Company’s expected stock price volatility
assumption is based upon the Company’s own implied volatility. As the Company has limited stock option exercise information, the
expected life assumption used for option grants is based upon the simplified method provided for under ASC 718. The dividend yield assumption
is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends.
The Company did not grant stock options during the
year ended December 31, 2024. For valuing options granted during the year ended December 31, 2023, the following assumptions were used:
Schedule of assumptions for option valuation
December 31,
2023
Risk-free interest rate
4.72 %
Expected volatility
113.74 %
Expected lives (in years)
5.25
Expected dividend yield
0 %
The weighted average grant date fair value of options
granted during the year ended December 31, 2023 was $ 1.14 per share.
F- 20
The following table summarizes the Company’s
stock option activity for the year ended December 31, 2024:
Schedule of stock option activity
Total Number
of Shares
Weighted-
Average
Exercise
Price
Per Share
Weighted-
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
Balance at December 31, 2022
20
$
317,082.58
Granted
1,136
12.33
Exercised
–
–
Forfeited
–
–
Expired
( 10
)
473,197.73
Balance at December 31, 2023
1,146
$
10,120.69
9.74 years
$
–
Granted
–
–
Exercised
–
–
Forfeited
–
–
Expired
( 20
)
512,001.27
Balance at December 31, 2024
1,126
$
1,206.29
8.71 years
$
–
Exercisable at December 31, 2024
1,126
$
1,206.29
8.71 years
$
–
Stock-based compensation expense related to stock options
for the years ended December 31, 2024 and 2023 was $ 6,000 and $ 5,000 , respectively.
As of December 31, 2024, there was no compensation
expense for unvested stock options.
There is no income tax benefit as the Company is currently
operating at a loss and an actual income tax benefit may not be realized.
Compensation Expense Related to Equity Awards
The following table sets forth total stock-based compensation
expense for the years ended December 31, 2024 and 2023, in thousands:
Schedule of stock-based compensation expense
December 31,
2024
2023
Research and development
$ 30
$ 132
General and administrative
117
171
Total stock-based compensation
$ 147
$ 303
10. Income Taxes
The provision for income taxes for the years ended
December 31, 2024 and 2023 are as follows, in thousands:
Schedule of provision for income taxes
Years Ended December 31,
2024
2023
Current
Federal
$ –
$ –
State
–
–
Total current
–
–
Deferred
Federal
1,589
( 1,831 )
State
623
( 718 )
Total deferred
2,212
( 2,549 )
Valuation allowance
( 2,212 )
2,549
Total provision for income taxes
$ –
$ –
F- 21
The following table presents a reconciliation of the
U.S. statutory tax rate to the Company’s actual effective income tax rate:
Schedule of effective income tax reconciliation
Years Ended December 31,
2024
2023
Federal statutory rate
21.0 %
21.0 %
State income taxes, net of federal benefit
10.6 %
5.9
Non-deductible expenses
( 0.8 % )
( 0.5 )
Income tax credits
0.1 %
2.1
Valuation allowance
( 30.9 % )
( 28.5 )
Effective tax rate
0.0 %
0.0 %
The Company recognizes deferred tax assets and liabilities
to reflect the tax effects of temporary differences between the tax basis of assets or liabilities and their reported amounts in the consolidated
financial statements in accordance with ASC 740. These temporary differences will result in taxable or deductible amounts in future years
when the reported amounts of the assets or liabilities are recovered or settled.
ASC 740 requires that a valuation allowance be
established when management determines that it is more likely than not that all or a portion of a deferred asset will not be
realized. The Company evaluates the realizability of its net deferred income tax assets and valuation allowances as necessary, at
least on an annual basis. During this evaluation, the Company reviews its forecasts of income in conjunction with other positive and
negative evidence surrounding the realizability of its deferred income tax assets to determine if a valuation allowance is required.
As a result of this evaluation, the Company has recorded a full valuation allowance against its deferred tax assets as the Company
believes it is more likely than not that the benefit of all of its deferred tax assets will not be realized. The federal valuation
allowance for the years ended December 31, 2024 and December 31, 2023 was $ 337,000
and $ 2,549,000 , respectively. The
decrease of $2,212,000 is primarily due to a reduction in carryforwards during the year ended December 31, 2024.
The significant components of the Company’s deferred
tax assets and liabilities are as follows, in thousands:
Schedule of deferred tax assets and liabilities
Years Ending December 31,
2024
2023
Deferred tax assets:
Net operating loss carryforwards
$ 26
$ 774
Tax credit carryforwards
5
295
Stock-based compensation
21
80
Capitalized research and development expenses
295
1,384
License fees
3
3
Lease liability
–
9
Other timing differences
–
13
Deferred tax assets
350
2,558
Deferred tax liabilities:
Right of use asset
–
( 9 )
Other timing differences
( 13 )
–
Deferred tax liability
( 13 )
( 9 )
Valuation allowance
( 337 )
( 2,549 )
Net deferred tax asset
$ –
$ –
F- 22
Ownership changes may limit the amount of net operating
loss (“ NOL ”) carryforwards or tax credit carryforwards that can be utilized to offset future taxable income or tax
liability. Pursuant to Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “ Code ”), NOL
and tax credit carryforwards may be subject to annual limitations in the event a cumulative change in ownership of more than 50% occurs
within a three-year period. Any limitation may result in expiration of a portion of the NOL carryforwards or tax credit carryforwards
before utilization.
During 2023, the Company completed an assessment of
the available NOL and tax credit carryforwards under Sections 382 and 383 of the Code since the last assessment completed in 2021 and
concluded that the Company underwent an ownership change in 2023. As a result, NOL and tax credit carryforwards attributable to the pre-ownership
change are subject to substantial annual limitations under Sections 382 and 383 of the Code. The Company adjusted its NOL and tax credit
carryforwards to address the impact of the ownership change. For the year ended December 31, 2023, federal and state NOLs were reduced
by $ 52,000,000 and $ 25,900,000 , respectively, and federal and state research and development tax credit carryforwards were reduced by
$ 918,000 and $ 517,000 , respectively, as a result of the ownership change in 2023. The Company may experience ownership changes in the
future as a result of subsequent shifts in stock ownership, some of which may be outside of the Company’s control.
For 2024, the Company updated its analysis to
determine the annual Section 382 NOL utilization limitation as a result of a change in ownership that occurred on December 20,
2024. As a result of this ownership change, the Company’s NOLs were reduced by $ 6,265,000 and $ 4,893,000 , respectively, and federal
and state research and development tax credits carryforwards were reduced by $ 401,000 and $ 174,000 , respectively.
At December 31, 2024, the Company had federal and state
NOL carryforwards of approximately $ 103,000 and $ 75,000 , respectively, to reduce future taxable income. The utilization of the federal
carryforwards as an available offset to future taxable income is subject to limitations under federal income tax laws. Under current federal
income tax law, federal NOLs generated in tax years beginning after December 31, 2017 may be carried forward indefinitely, but are limited
to offset up to 80% of future taxable income. As of December 31, 2024, all our federal NOL carryforwards will carryforward indefinitely.
The Company’s available state NOL carryforwards will begin to expire in 2045, unless previously utilized.
At December 31, 2024, the Company also had
federal research and development credits of approximately $ 5,000 ,and no
state research and development credits. The
federal tax credit carryforwards will begin to expire in 2045.
The Company has not recorded any uncertain tax positions
as of December 31, 2024 or 2023. The Company does no t believe there will be any material changes in its unrecognized tax positions
over the next 12 months.
The Company has no t incurred any interest or penalties.
In the event that the Company is assessed interest or penalties at some point in the future, they will be classified in the consolidated
financial statements as income tax expense.
The Company files income tax returns in the United
States and in multiple state jurisdictions. The Company is subject to tax examinations for federal and state purposes for tax years 2021
through 2024.
11. Net Loss per Share
Basic net loss per share is computed by dividing net
loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing the Company’s
net loss by the weighted average number of common shares outstanding and the impact of the dilutive effect of potential common stock equivalents,
except when the inclusion of such potential common stock equivalents would be anti-dilutive. Dilutive potential common stock equivalents
primarily consist of stock options, RSUs and warrants. Therefore, basic and diluted net loss per share applicable to common stockholders
were the same for all periods presented because the impact of these items is generally anti-dilutive during periods of net loss.
F- 23
The following table sets forth the potential common
shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive:
Schedule of antidilutive shares
December 31,
2024
2023
Stock options
1,126
10,084
Unvested restricted stock units
71,000
49,683
Warrants
1,925,867
5,504,918
Total
1,997,993
5,564,685
12. Segment Information
The Company is a clinical stage biotechnology company
that has yet to generate operating revenues. Management has determined that the Company operates with a single operating segment and a
single reporting segment – the Clinical segment. The Chief Operating Decision Maker (CODM) is the Chief Executive Officer (CEO).
The CEO assesses performance and allocates resources to achieve the Company’s goals based on operating income/(loss) and net income/(loss)
as reported in the Consolidated Statements of Operations. The measure of segment assets is Total Assets as presented on the Consolidated
Balance Sheets. All of the Company’s operations occur within the United States.
The following table presents selected financial information
with respect to the Company's single operating segment (in thousands):
Segment information
December 31,
2024
2023
Research and development expense
$ ( 3,643 )
$ ( 6,332 )
General and administrative expense
( 3,744 )
( 4,366 )
Impairment loss on property and equipment
–
( 126 )
Other income
6
6
Interest income
244
3
Interest expense
( 13 )
( 11 )
Net loss
$ ( 7,150 )
$ ( 10,826 )
Total assets
$ 5,738
$ 9,364
13. Subsequent Events
On January 13, 2025, the Company entered into
a securities purchase agreement (the “ January 13, 2025 Securities Purchase Agreement ”) with certain institutional and
accredited investors in connection with a registered direct public offering (the “ January 13, 2025 Registered Direct Offering ”)
and concurrent private placement (the “ January 13, 2025 Private Placement ” and, together with the January 13, 2025
Registered Direct Offering, the “ January 13, 2025 Offerings ”). The January 13, 2025 Offerings closed on January 14,
2025. In addition, the Company issued warrants to the placement agent, HCW, to purchase a total of 79,775 shares of Common
Stock at an exercise price of $3.75 per share. The net proceeds to the Company from the January 13, 2025 Registered Direct Offerings and
the January 13, 2025 Private Placement is approximately $2.9 million, after deducting fees and estimated offering expenses.
F- 24
Pursuant to the January 13, 2025 Securities Purchase
Agreement, the Company offered and sold in the January 13, 2025 Registered Direct Offering 1,063,670 shares of Common Stock at a purchase
price of $3.00 per share. In the January 13, 2025 Private Placement, the Company also issued to certain institutional and accredited investors
unregistered warrants to purchase up to 2,127,340 shares of Common Stock (the “ Series G Warrants ”). Under the terms
of the January 13, 2025 Securities Purchase Agreement, for each share of Common Stock issued in the January 13, 2025 Registered Direct
Offering, two accompanying Series G Warrants were issued to the purchaser thereof. Each Series G Warrant is exercisable for one share
of Common Stock at an exercise price of $3.00 per share and will expire on January 14, 2027.
On January 14, 2025, the Company entered into
a securities purchase agreement (the “ January 14, 2025 Securities Purchase Agreement ”) with certain institutional and
accredited investors in connection with a registered direct public offering (the “ January 14, 2025 Registered Direct Offering ”)
and concurrent private placement (the “ January 14, 2025 Private Placement ” and together with the January 14, 2025 Registered
Direct Offering, the “ January 14, 2025 Offerings ”). The January 14, 2025 Offerings closed on January 15, 2025. In addition,
the Company issued warrants to the placement agent, HCW, to purchase a total of 62,500 shares of Common Stock at an exercise price of
$3.75 per share. The net proceeds to the Company from the January 14, 2025 Registered Direct Offering and the January 14, 2025 Private
Placement are approximately $2.2 million, after deducting fees and estimated offering expenses.
Pursuant to the January 14, 2025 Securities Purchase
Agreement, the Company offered and sold in the January 14, 2025 Registered Direct Offering 833,335 shares of Common Stock
at a purchase price of $3.00 per share. In the January 14, 2025 Private Placement, the Company also issued to such institutional
and accredited investors unregistered warrants to purchase up to 1,666,670 shares of Common Stock (the “ Series H Warrants ”).
Under the terms of the January 14, 2025 Securities Purchase Agreement, for each share of Common Stock issued in the January
14, 2025 Registered Direct Offering, two accompanying Series H Warrants were issued to the purchaser thereof. Each Series H Warrant
is exercisable for one share of Common Stock at an exercise price of $3.00 per share and will expire on January 15, 2027.
On January 16, 2025, the Company entered into
a securities purchase agreement (the “ January 16, 2025 Securities Purchase Agreement ”) with certain institutional and
accredited investors in connection with a registered direct public offering (the “ January 16, 2025 Registered Direct Offering ”)
and concurrent private placement (the “ January 16, 2025 Private Placement ” and together with the January 16, 2025 Registered
Direct Offering, the “ January 16, 2025 Offerings ”). The January 16, 2025 Offerings closed on January 17, 2025. In addition,
the Company issued warrants to the placement agent, HCW, to purchase a total of 45,750 shares of Common Stock at an exercise price of
$3.75 per share The net proceeds to the Company from the January 16, 2025 Registered Direct Offering and the January 16, 2025 Private
Placement are approximately $1.6 million, after deducting fees and estimated offering expenses.
Pursuant to the January 16, 2025 Securities Purchase
Agreement, the Company offered and sold in the January 16, 2025 Registered Direct Offering 610,000 shares of Common Stock
at a purchase price of $3.00 per share. In the January 16, 2025 Private Placement, the Company also issued to such institutional
and accredited investors unregistered warrants to purchase up to 1,220,000 shares of Common Stock (the “ Series I Warrants ”).
Under the terms of the January 16, 2025 Securities Purchase Agreement, for each share of Common Stock issued in the January
16, 2025 Registered Direct Offering, two accompanying Series I Warrants were issued to the purchaser thereof. Each Series I Warrant
is exercisable for one share of Common Stock at an exercise price of $3.00 per share and will expire on January 19, 2027.
F- 25
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.